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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83946

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 23, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Siemens Healthcare Diagnostics, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Atellica CH 930 Analyzer

Z-0581-2020
Recall number
Z-0581-2020
Initiated
September 23, 2019
Classification
Class II
Status
Terminated
Quantity
1432

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher.

Code information

SMN 11067000, Software V1.20.0 and Lower, UDI 00630414002163

Distribution pattern

Distributed to accounts located in AL AZ AR CA CO FL GA IL IN IA KS KY LA MA MI MN MS NE NV NH NJ NM NY NC OH OR PA SC TN TX UT WA WV DC PR. Foreign distribution to AR AU AT BS BD BE BR BG CA CL CO CW CZ DK EG FI FR DE GR HU IN IR IE IL IT JP KW LV MY MX NL NG NO CN PK PH PL PT QA KR RO RU SA SG SK ZA ES SE CH TW TH TR AE GB UY VN.